Clinical Trials

Numerous clinical trials evaluate methimazole across Early Phase 1 through Phase 4, focusing primarily on thyroid disorders—including Graves' disease, hyperthyroidism, toxic nodular goiter, and Graves' orbitopathy—and glioblastoma multiforme. Sponsored by academic medical centers, health systems, and pharmaceutical entities, these studies reflect recruitment statuses ranging from recruiting and completed to suspended, terminated, or unknown. Investigational approaches include adjunctive nutritional interventions in pediatric cohorts and combination metabolic therapies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06240455 SUSPENDED
Graves Disease
Worg Biotherapeutics Inc.
2026-03-31 PHASE2
NCT07369063 RECRUITING
Graves Disease; Graves' Disease; Hyperthyroidism
Northwell Health
2025-08-01 PHASE2
NCT06327828 NOT_YET_RECRUITING
Graves Disease
Medical University of Graz
2024-09-01
NCT05607407 SUSPENDED
Glioblastoma; Glioma
Case Comprehensive Cancer Center
2023-01-30 PHASE2
NCT06068179 RECRUITING
Graves' Disease
The First Affiliated Hospital of Xiamen University
2023-10-16 PHASE2; PHASE3
NCT04946123 COMPLETED
Hyperthyroidism
Lo.Li.Pharma s.r.l
2021-07-05
NCT04776993 UNKNOWN
Graves' Orbitopathy
University of Pisa
2023-03-02 PHASE3
NCT05461820 RECRUITING
Graves Disease; Relapse; Treatment; Drug Withdrawal
The First Affiliated Hospital with Nanjing Medical University
2018-05-01 PHASE4
NCT05017610 WITHDRAWN
Recurrent Glioblastoma; Recurrent Gliosarcoma
Emory University
2021-10-20 EARLY_PHASE1
NCT05118542 COMPLETED
Hyperthyroidism; Graves Disease; Atherosclerosis of Artery; Pathophysiology
Indonesia University
2019-01-01 PHASE3
NCT02654041 TERMINATED
Glioblastoma Multiforme (GBM)
Musli Thyropeutics Ltd.
2016-03 PHASE2
NCT01458600 COMPLETED
Graves´ Disease
Mikael Lantz
2006-09 PHASE4
NCT02727738 COMPLETED
Graves' Disease
University of Pisa
2014-01
NCT01849861 UNKNOWN
Healthy
Universidade Federal do Rio de Janeiro
2011-09 PHASE4
NCT01893450 TERMINATED
Graves Ophthalmopathy
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
2008-06
NCT01560299 COMPLETED
Graves Disease
Mashhad University of Medical Sciences
2010-02
NCT01849861 Unknown status
Healthy
Universidade Federal do Rio de Janeiro|Conselho Nacional de Desenvolvimento Científico e Tecnológico
2011-09 Phase 4
NCT00150124 COMPLETED
Toxic Nodular Goitre; Graves' Disease
Steen Bonnema
2003-01 PHASE4
NCT00001421 COMPLETED
Dermatomyositis; Polymyositis
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1995-06 PHASE2
NCT00150111 COMPLETED
Graves´ Disease; Thyroid Associated Ophthalmopathy
Odense University Hospital
2003-06 PHASE1; PHASE2
NCT00150137 COMPLETED
Toxic Nodular Goitre; Graves Disease
Odense University Hospital
2003-01 PHASE4

(data from https://clinicaltrials.gov, updated on 2025-05-08)

Check the Methimazole product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Methimazole selectively binds to and inhibits the enzyme thyroperoxidase, thereby blocking the organification of iodide and preventing the enzymatic incorporation of iodine into thyroglobulin. By suppressing the downstream biosyntheses of triiodothyronine and thyroxine in follicular cells, this inhibition lowers circulating thyroid hormone levels to relieve hyperhormonemia in clinical trial conditions including hyperthyroidism, Graves' disease, and glioblastoma multiforme.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.